Long-Term Durability of Transcatheter Aortic Valve Implantation With Self-Expandable Valve System (From a Real-World Registry).
As transcatheter aortic valve Implantation (TAVI) moves to younger and lower risk patients with longer life expectancy, the long-term durability of TAVI is becoming an increasingly relevant issue. We sought to evaluate the long-term clinical outcome and prosthesis performance of the CoreValve self-expandable valve. Clinical registry of 182 patients consecutively treated with TAVI in a tertiary center from January 2009 to July 2017. Of these, 111 died during an average follow-up (FU) of 1,026±812 days (median IQR: 745, 477-1,400 days; longest survival 11 years; 61% mortality at Kaplan-Meier analysis). At 1 month, functional profile improved in all survivors, with 93.9% of them achieving NYHA class I or II. At Cox analysis, the Society of Thoracic Surgeons score (HR: 1.55; p=0.001), left ventricular ejection fraction <40% (HR: 1.65; p=0.017) and incident acute kidney injury (HR: 1.96; p=0.001) were independently associated with all-cause mortality. During FU, echocardiographically assessed mean transprosthetic aortic gradient remained substantially unchanged (from 9.0±2.7 post TAVI to 9.0±5.0 mmHg at FU; p>0.05). Most patients had none/trivial (34%) or mild (58%), fewer had moderate (8%) and none had severe perivalvular leak, without significant change during FU. At 11 years, cumulative incidence of bioprosthetic valve failure (BVF) and moderate structural valve deterioration (SVD) were 2.9% (95% CI 0.8-10%) and 9.3% (95% CI 3.3-26.7%), respectively. In conclusion, our registry confirmed that TAVI with the self-expandable CoreValve system was associated with favorable long-term clinical outcomes, with a reassuring low rate of significant BVF and moderate SVD.